Dipole Density Mapping in Supraventricular Tachycardia

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-06

Study Completion Date

2017-05-22

Brief Summary

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Use of dipole density mapping to identify activation in complex supraventricular tachycardias.

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Detailed Description

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The research study was conducted in multiple countries throughout the EU and Canada. The protocol and their corresponding NCT numbers are as follows:

NCT01914549 (Protocol CL-SVT-001, Site Belgium, Bruges Dr. Duytschaever = PI) NCT01875614 (Protocol CL-SVT-002, Sites in the UK, Drs. Grace, Hall, \& Schilling = PIs) NCT03368781 (Protocol CL-SVT-004, Site Hamburg, Germany Prof. Willems = PI) NCT02469623 (Protocol CL-SVT-005, Site Prague, Czech Republic Prof. Neuzil = PI) NCT02469636 (Protocol CL-SVT-006, Site Santiago, Chile Dr. Bittner = PI) NCT02469649 (Protocol CL-SVT-008, Site Ontario, Canada Dr. Verma = PI)

All of the above records were combined into one as all protocols were essentially identical and one study report was written that encompasses the data/results for all protocols.

Conditions

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Supraventricular Tachycardia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Dipole Density Mapping

Group Type EXPERIMENTAL

Dipole Density Mapping with AcQMap followed by ablation

Intervention Type DEVICE

Interventions

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Dipole Density Mapping with AcQMap followed by ablation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Be aged 18-75 years
2. Be scheduled for ablation of an SVT due to the arrhythmia being recurrent, poorly tolerated, and /or unable to be controlled with antiarrhythmic drugs.
3. Be able and willing to give informed consent

Exclusion Criteria

1. Have any of the following:

* implanted prosthetic, artificial, or repaired cardiac valves in the chamber being mapped
* permanent pacemaker or ICD leads in the chamber being mapped
* hypercoagulopathy or an inability to tolerate anticoagulation during the procedure
* Stents in the area of the pulmonary veins (Study CL-SVT-004 ONLY)
2. MI within the prior two (2) months
3. Cardiac surgery within the prior three (3) months
4. Intracardiac thrombus
5. Clinically significant tricuspid and/or mitral valve regurgitation or stenosis
6. Cerebral ischemic event (including TIA) in the prior six (6) months
7. Pregnant or nursing
8. Currently enrolled in another clinical investigation
9. Have a contraindication for transfemoral venous access (Study CL-SVT-004 ONLY)
10. Have a contraindication for transseptal left atrial access (for patients with left atrial arrhythmias) (Study CL-SVT-004 ONLY)
11. Life expectancy of less than one (1) year (Study CL-SVT-004 ONLY)
12. Any health condition that, in the Investigator's opinion, would not allow the application of the investigational device (Study CL-AF-004 ONLY)

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Petr Neuzil, MD

Role: PRINCIPAL_INVESTIGATOR

Nemocnice Na Homolce

Locations

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AZ Sint-Jan AV Cardiologie

Bruges, , Belgium

Site Status

Southlake Regional Health Center

Newmarket, Ontario, Canada

Site Status

Pontificia Universidad Catolica de Chile

Santiago, , Chile

Site Status

Na Homolce Hospital

Prague, , Czechia

Site Status

Elektrophysiologie Universitätsklinikum Hamburg-Eppendorf

Hamburg, , Germany

Site Status

Papworth Hospital NHS Foundation Trust

Cambridge, , United Kingdom

Site Status

Liverpool Heart and Chest Hospital

Liverpool, , United Kingdom

Site Status

Barts Health NHS Trust

Whitechapel, , United Kingdom

Site Status

Countries

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Belgium Canada Chile Czechia Germany United Kingdom

References

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Grace A, Willems S, Meyer C, Verma A, Heck P, Zhu M, Shi X, Chou D, Dang L, Scharf C, Scharf G, Beatty G. High-resolution noncontact charge-density mapping of endocardial activation. JCI Insight. 2019 Mar 21;4(6):e126422. doi: 10.1172/jci.insight.126422. eCollection 2019 Mar 21.

Reference Type DERIVED

PMID: 30895945 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document